FDA UDI
In Commercial Distribution
🇺🇸 United States
ExtendSURE
DI: 09421902348006
·
Model: B12396
·
CANTERBURY SCIENTIFIC LIMITED
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ExtendSURE
- Primary DI
- 09421902348006
- Version / Model
- B12396
- Company Name
- CANTERBURY SCIENTIFIC LIMITED
- Labeler DUNS
- 590649471
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 2
- Public Version Date
- 2019-07-24
- Public Version Status
- Update
- Public Device Record Key
- 1a5f30b5-4602-4bc9-9187-61f063a0bec1
Device Description
The liquid Hemoglobin A1c Control kit contains 2 vials each of level 1 and level 2 controls which are prepared as a stabilized hemolysate from human blood. The controls are designed for use as quality control materials to monitor the accuracy and precision of laboratory testing procedures.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Clinical Chemistry | 862.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44435 | Glycated haemoglobin (HbA1c) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin, in a clinical specimen. | No | Active |
| 52856 | Glucose/haemoglobin (Hb) IVD, control | A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose and haemoglobin (Hb) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09421902348006 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius